Laurence McCullough

The clinical application of the concept of patient autonomy has centered on the ability to deliberate and make treatment decisions to the virtual exclusion of the capacity to execute the treatment plan. However, the one-component concept of autonomy is problematic in the context of multiple chronic conditions. Adherence to complex treatments commonly breaks down when patients have functional, educational, and cognitive barriers that impair their capacity to plan, sequence, and carry out tasks associated with chronic care. The purpose of this article is to call for a two-component re-conceptualization of autonomy and to argue that the clinical assessment of capacity for patients with chronic conditions should be expanded to include both autonomous decision-making and autonomous execution of the agreed-upon treatment plan. We explain how the concept of autonomy should be expanded to include both decisional and executive autonomy, describe the biopsychosocial correlates of the two-component concept of autonomy, and recommend diagnostic and treatment strategies to support patients with deficits in executive autonomy.

The pluralism of methodologies and severe time constraints pose important challenges to pedagogy in clinical ethics. We designed a step-by-step student handbook to operate within such constraints and to respect the methodological pluralism of bioethics and clinical ethics. The handbook comprises six steps: Step 1: What are the facts of the case?; Step 2: What are your obligations to your patient?; Step 3: What are your obligations to third parties to your relationship with the patient?; Step 4: Do your obligations converge or conflict?; Step 5: What is the strongest objection that could be made to the identification of convergence in step 4 or the arguments in step 4? How can this objection be effectively countered?; and Step 6: How could the ethical conflict, or perceived ethical conflict, have been prevented?

When healthcare resources become overwhelmed in medical disasters, as they inevitably will, we have to ask, in an unflinching fashion, the question: “What then?” or more precisely, “What should we do when we run out of resources?” In a mass casualty event worthy of the designation, we will indeed run out of resources, perhaps quite quickly. This article provides an ethical framework for the responsible management of medical disasters in which the “What then?” question must be asked. The framework begins with a critique of existing guidance from professional associations of physicians and then argues for an alternative approach that qualifies the obligation to preserve life, takes seriously the ethical challenges of overwhelmed healthcare resources, and countenances physician-assisted suicide as a last resort.

On February 3, 2010, a “Letter of Concern from Bioethicists,” organized by fetaldex.org, was sent to report suspected violations of the ethics of human subjects research in the off-label use of dexamethasone during pregnancy by Dr. Maria New. Copies of this letter were submitted to the FDA Office of Pediatric Therapeutics, the Department of Health and Human Services (DHHS) Office for Human Research Protections, and three universities where Dr. New has held or holds appointments. We provide a critical appraisal of the Letter of Concern and show that it makes false claims, misrepresents scientific publications and websites, fails to meet standards of evidence-based reasoning, makes undocumented claims, treats as settled matters what are, instead, ongoing controversies, offers “mere opinion” as a substitute for argument, and makes contradictory claims. The Letter of Concern is a case study in unethical transgressive bioethics. We call on fetaldex.org to withdraw the letter and for co-signatories to withdraw their approval of it

Taking the critical turn is one of the main tools of the humanities and inculcates an intellectual discipline that prevents ossification of thinking about issues and of organizational policies in clinical ethics. The articles in this "Clinical Ethics" number of the Journal take the critical turn with respect to cherished ways of thinking in Western clinical ethics, life extension, the clinical determination of death, physicians' duty to treat even at personal risk, clinical ethics at the interface of research ethics, and the pertinence of the Hippocratic Oath to clinical ethics. These articles challenge clinical ethicists to inculcate the intellectual discipline of the critical turn into everyday practice and continuous quality enhancement of clinical ethics.

Making finely crafted distinctions and deploying them in intellectually rigorous and clinically applicable judgments define, to a considerable degree, the art of clinical ethics. The papers in this Clinical Ethics number of the Journal of Medicine and Philosophy demonstrate the art of clinical ethics in their consideration of respect for autonomy vs. respect for persons, the role of risk in triggering assessment of decisional capacity vs. the role of risk in the concept and assessment of decisional capacity, intention vs. foresight in the clinical management of ectopic pregnancy, preserving life vs. relieving suffering in physician-assisted suicide, and what is essential vs. non-essential in defining the core areas of ethics education for members of hospital ethics committees.

Physicians make some medical decisions without disclosure to their patients. Nondisclosure is possible because these are silent decisions to refrain from screening, diagnostic or therapeutic interventions. Nondisclosure is ethically permissible when the usual presumption that the patient should be involved in decisions is defeated by considerations of clinical utility or patient emotional and physical well-being. Some silent decisions - not all - are ethically justified by this standard. Justified silent decisions are typically dependent on the physician's professional judgment, experience and knowledge, and are not likely to be changed by patient preferences. We condemn the inappropriate exclusion of the patient from the decision-making process. However, if a test or treatment is unlikely to yield a net benefit, disclosure and discussion are at times unnecessary. Appropriate silent decisions are ethically justified by such considerations as patient benefit or economy of time.

The clinical ethics literature is striking for the absence of an important genre of scholarship that is common to the literature of clinical medicine: systematic reviews. As a consequence, the field of clinical ethics lacks the internal, corrective effect of review articles that are designed to reduce potential bias. This article inaugurates a new section of the annual "Clinical Ethics" issue of the Journal of Medicine and Philosophy on systematic reviews. Using recently articulated standards for argument-based normative ethics, we provide a systematic review of the literature on concealed medication for the management of psychiatric disorders. Four steps are completed: identify a focused question; conduct a literature search using key terms relevant to the focused question; assess the adequacy of the argument-based methods of the papers identified; and identify conclusions drawn in each paper and whether they apply to the focused question. We identified seven papers and provide an assessment of them. While none of the papers fully meet the standards of argument-based ethics, they did provide rationales for the use of concealed medications, with the important requirement such a practice be accountable in explicit organizational policy to prevent abuse of patients with mental illness or dementia.

Managed care employs two business tools of managed practice that raise important ethical issues: paying physicians in ways that impose conflicts of interest on them; and regulating physicians' clinical judgment, decision making, and behavior. The literature on the clinical ethics of managed care has begun to develop rapidly in the past several years. Professional organizations of physicians have made important contributions to this literature. The statements on ethical issues in managed care of four such organizations are considered here, the American Medical Association, the American College of Physicians, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics. Three themes common to these statements are identified and critically assessed: the primacy of meeting the medical needs of each individual patient; disclosure of conflicts of interest in how physicians are paid; and opposition to gag orders. The paper concludes with an argument for a basic concept in the clinical ethics of managed care: physicians and institutions as economically disciplined moral co-fiduciaries of populations of patients.

On February 3, 2010, a “Letter of Concern from Bioethicists,” organized by fetaldex.org, was sent to report suspected violations of the ethics of human subjects research in the off-label use of dexamethasone during pregnancy by Dr. Maria New. Copies of this letter were submitted to the FDA Office of Pediatric Therapeutics, the Department of Health and Human Services Office for Human Research Protections, and three universities where Dr. New has held or holds appointments. We provide a critical appraisal of the Letter of Concern and show that it makes false claims, misrepresents scientific publications and websites, fails to meet standards of evidence-based reasoning, makes undocumented claims, treats as settled matters what are, instead, ongoing controversies, offers “mere opinion” as a substitute for argument, and makes contradictory claims. The Letter of Concern is a case study in unethical transgressive bioethics. We call on fetaldex.org to withdraw the letter and for co-signatories to withdraw their approval of it.